The FDA has determined that any level of melamine in baby formula, no matter how small, is a safety concern.
by Peggy Peck, Executive Editor, MedPage Today
ROCKVILLE, Md., Oct. 3 — Any level of melamine in baby formula, no matter how small, is a safety concern, but the precise level of risk cannot be quantified, the FDA said today.
But the agency added in an interim safety and risk assessment that in food products other than baby formula, melamine concentrations of less than 2.5 parts per million “do not raise concerns.”
For baby feeding, confounding factors such as infant size, maturity, and whether formula was the sole source of nutrition, complicate risk assessments, the FDA said.
But while there was “too much uncertainty to set a level in infant formula and rule out any public health concern,” the FDA added that was important to understand “that this does not mean that any exposure to any detectable level of melamine and melamine-related compounds in formula will result in harm to infants.”
The FDA performed the assessment in response to public health concerns raised by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China.
The assessment was conducted by scientists from FDA’s Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity.
The FDA said, however, that there were significant “gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants.”
The agency noted that there are questions about continual use of melamine-contaminated infant formula as the sole source of nutrition, and whether more than one melamine analog could be ingested.
Moreover, the FDA said that risks might be greater for premature infants who have immature kidney function. Because preemies are smaller than full-term infants, they might, on “a body-weight basis, experience greater levels of intake for a longer time than is experienced by term infants.”
In other food products, the FDA concluded that “levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns.”
That conclusion assumed a “worst-case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.”
In the past week, the FDA announced recalls of instant coffee and tea products imported from China due to suspected melamine contamination. (See: Chinese Melamine Contamination Prompts 21-State Recall)
Related Article(s): Chinese Melamine Contamination Prompts 21-State Recall
Reviewed by Zalman S. Agus, MD; Emeritus Professor, University of Pennsylvania School of Medicine.
Published: October 03, 2008
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